Oral Mucosal Absorption Study of Bicalutamide New Formulation

NCT01416883 | Terminated Phase 1

• 1 other identifier: D6874L00016
• Study Type: interventional
• Target: 8
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to investigate the presence or absence of oral mucosal absorption of bicalutamide after ICI176,334.1 is given to Japanese healthy male subjects

Conditions

Healthy

Keywords

oral mucosal absorption; pharmacokinetics; safety; bicalutamide; Japanese; healthy subject

Outcome Measures

Primary Outcomes (2)

• To investigate the presence or absence of oral mucosal absorption of ICI176,334-1 by assessment of concentration of bicalutamide in saliva.

  Blood samples are taken repeatedly for 72 hours and also taken at 168 hours after application of the investigational drug.

• To investigate the presence or absence of oral mucosal absorption of ICI176,334-1 by assessment of concentration of bicalutamide in plasma.

  Blood samples are taken repeatedly for 72 hours and also taken at 168 hours after application of the investigational drug.

Secondary Outcomes (3)

• To assess the safety by assessment of adverse event.

  Subjects will be monitored for adverse events prior to treatment and up to 14 to 21 days (follow-up) after application of the investigational drug.

• To assess the safety by assessment of vital signs.

  Subjects will be monitored for vital signs prior to treatment and up to 14 to 21 days (follow-up) after application of the investigational drug.

• To assess the safety by assessment of electrocardiograms (ECGs).

  Subjects will be monitored for electrocardiograms (ECGs) prior to treatment and up to 14 to 21 days (follow-up) after application of the investigational drug.

Study Arms (1)

Active 1

EXPERIMENTAL

8 subjects will receive ICI176,334-1

Drug: ICI176,334-1

Interventions

ICI176,334-1 DRUG

Subject will receive single dose of ICI176,334-1

Active 1

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Provision of signed and dated, written informed consent prior to any study specific procedures
• Japanese healthy male subjects aged 20 to 45 years
• Male subjects should be willing to use barrier contraception ie, condoms, until 3 months after the last dose of investigational product
• Have a body mass index (BMI) between 17 and 27 kg/m2
• Eligible based on the physical findings, supine BP, pulse rate, ECG and laboratory assessments, as judged by the investigator(s)

You may not qualify if:

• Presence of any disease under medical treatment
• History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, immunological, blood, endocrine, neurological or mental disease to interfere with absorption, distribution, metabolism or excretion of drugs judged by investigator(s)
• Presence of any infectious disease, such as bacteria, virus and fungus Presence of allergic disorder, such as asthma, pollen disease or atopic dermatitis, and judged as necessary any medical treatment
• Any large surgical history of gastrointestinal tract such as gastric/intestinal resection or suturation

Sponsors & Collaborators

• AstraZeneca: lead

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 12, 2011
• First Posted: August 15, 2011
• Study Start: July 1, 2010
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: August 15, 2011

Record last verified: 2011-08